Clinical trial

Intravenous Lidocaine for Treating Intrathecal Fentanyl Induced Pruritus

Name

KACS, KSA: H-08- L-074

Description

The study will assess efficacy of intravenous lidocaine 1 mg/kg diluted with 0.9% sodium chloride to a volume of 100 ml to suppress intrathecal fentanyl induced pruritus. This will be compared to control group who will receive 100 ml normal saline as placebo. The main outcome is regression of initial VAS score with incidence of pruritus.

Trial arms

Trial start

2024-03-01

Estimated PCD

2024-09-01

Trial end

2024-10-01

Status

Not yet recruiting

Phase

Early phase I

Treatment

Lidocaine IV

The study group will receive lidocaine (2%) 1mg/ kg iv diluted by normal saline to a volume of 100 ml. The VAS will be assessed every 10 minutes for 60minutes after the treatment. A regression of more than 4 points of VAS score is considered a success and if less than 4 points , it will be considered as a failure.

Arms:

Control group, Study group

Size

Primary endpoint

regression of VAS in comparison to initial pruritus scale.

The whole perioperative period

Eligibility criteria

Inclusion Criteria: * patients who are admitted for orthopedic operations and Urosurgery who are planned to receive spinal anesthesia. * The study will include adult patients aging from 18 to 70 years old. ASA I to III. Exclusion Criteria: * the patients who receive antihistamine drugs * patients who suffer any type of coagulopathy * patients who are suffering any type of pruritus before receiving spinal anesthesia * patients who are known allergic to lidocaine.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, prospective trial on 2 equal groups', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'Preparation of the used infusion volume will performed by anesthesia specialist in our center not sharing in the study, he is the one who know it is placebo or lidocaine. The infusion performed blindly by the researcher and VAS will be assessed by the circulating nurse inside the theater or the nurse in the PACU.\n\nThe regression of VAS in comparison to initial pruritus scale will be recorded in both groups. The percentage of incidence of pruritus, body distribution of pruritus, duration of spinal anesthesia and local anesthetic toxicity symptoms will be recorded.', 'whoMasked': ['CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 54, 'type': 'ESTIMATED'}}

Updated at

2024-02-06

1 organization

1 product

1 indication

Organization

Ain Shams University

Product

Lidocaine

Indication

Drug-induced Pruritus